T2 Biosystems Inc (TTOO)

[BeamMeUpScotty]

Apparently there’s a very fine distinction between FDA Cleared and FDA Approved.


Here’s an extract from the website below:

“But the terminology you use does in fact matter. FDA has provided definitive guidance that the terms Clearance, Approval, and Granted each have their own unique meaning for a medical device regulatory submission route.”


Here’s a link explaining the difference.

https://www.greenlight.guru/blog/fda-clearance-approval-granted